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Completed

NCT Number: NCT00964314

Traditional Chinese Medicine Five Elements Music Therapy Improving Quality of Life in Patients With Advanced Cancer

The study objective is to evaluate the effectiveness of Traditional Chinese Medicine (TCM) five elements music therapy improving quality of life for patients with advanced cancer, as well as establishing the standard operating procedures (SOP) for it.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xi-Yuan Hospital, China Academy of Chinese Medical Sciences, Beijing, Beijing Municipality, China

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About this study

Design: As randomized controlled trial (RCT) with un-blinded design will be done.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eligible participation will be enrolled based on diagnostic criteria.
  • Advanced cancer patient with more than 50 scores of Karnofsky Performance Score (KPS).
  • Diagnosis of advanced cancer
  • Patients who are willing to be subject with taking part in this research voluntarily.
  • No prior experience with TCM music therapy.
  • Newly admitted to TCM oncology department for 3 weeks treatment course.

Exclusion criteria

  • Complicated diagnose or one who don't consistent with inclusion criteria.
  • Patients suffering from psychosis or diagnosis, or psychiatric diagnoses (e.g., schizophrenia).
  • Suffering from acute organ prostration or other condition of demanding to rescue，inability for accepting music therapy.
  • One don't read or fill in diary owing to some causes, such as state of the art or acuity of vision
  • One suffering from hearing disturbance
  • Accepted TCM five elements music therapy in the past.

Treatment and study plan

Music

Other

Experimental Group one : Listening TCM five elements music therapy（TCMMT）based on conventional therapy in China.

Experimental Group two: Listening western music based on conventional therapy in China.

Control Group: no music therapy will be done.

Primary outcomes

  1. Comparison of KPS Qol, and Diary at baseline and endpoint in each group (data for < 70 year old group).

    Time frame: Difference of(pro-post)treatment for KPS,Qol, Diary

    Comparison of Qol, KPS, Diary at baseline and endpoint, the result shown here were significantly different for all terms in TCM five elements music group, p=0. p=0.0015, p=0.0015 respectively. However, no significant difference was seen for all terms in Western music group and the no music group respectively (See Table 3).

  2. Comparison of KPS Qol, and Diary at baseline and endpoint in each group (data for the >70 year old group).

    Time frame: Difference of(pro-post)treatment for KPS,Qol, Diary

    Comparison of Qol, KPS and Diary score at baseline and endpoint results show there was a significant difference for the QoL in TCM five elements music group, p value is 0.0062. However, there was no significant difference for the KPS and Diary score in each group respectively(See Table 4).

Sponsors and collaborators

Lead sponsor

Ministry of Science and Technology of the People´s Republic of China

Other Gov

Collaborators

  • M.D. Anderson Cancer Center

Registry information

Official study title

Prospective Study With RCT Designed for Evaluation of TCM Five Elements Music Therapy Improving Quality of Life in Patients With Advanced Cancer

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 24, 2009
Registry last updated
Apr 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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